Kornimate/medical-research-clean huggingface dataset:
a study to assess efficacy and safety of the beta-3 agonist mirabegron (ym178) in patients with symptoms of overactive bladder

Conditions: Urinary Bladder, Overactive

Summary: the study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder


Eligibility criteria:
inclusion criteria: * patient is willing and able to complete the micturition diary and questionnaires correctly * patient has symptoms of overactive bladder for ≥ 3 months * patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period * patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period exclusion criteria: * patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control * patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor * patient has an indwelling catheter or practices intermittent self-catheterization * patient has diabetic neuropathy * patient has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs * patient receives non-drug treatment including electro-stimulation therapy * patient has severe hypertension * patient has a known or suspected hypersensitivity to ym178, other beta-adrenoreceptor (ß-ar) agonists, or any of the other inactive ingredients * patient has been treated with any investigational drug or device within 30 days * patient had an average total daily urine volume \> 3000 ml as recorded in the 3-day micturition diary period * patient has serum creatinine of \>150 μmol/l, or aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2x upper limit of normal range (uln), or gamma glutamyl transferase (γ-gt) \> 3x uln * patient has a clinically significant abnormal electrocardiogram (ecg)

Keywords: frequency ym178 overactive bladder (oab) micturition urgency urinary urge incontinence urinary incontinence
thrive person-centered planning program for young adults with fetal alcohol spectrum disorders

Conditions: Fetal Alcohol Spectrum Disorders

Summary: this study is testing a new program called thrive. the thrive program was developed for young adults with fetal alcohol spectrum disorders (fasd). thrive uses a person-centered planning approach, which means it focuses on what is most important to the young adult with fasd. the young adult invites people that support them to help them make plans to meet their goals. 60 young adults with fasd will participate in this study. half of the young adults will try out the thrive program immediately. the other half will be on a waitlist and will get to start the program about 8 months later. everyone completes online surveys at three times during the study. they do surveys at the beginning of the study, after 4 months, and after 8 months. the goal of the study is to test if the thrive program helps young adults meet their goals and get support when they need it.

this type 1 hybrid effectiveness-implementation trial proposes a 2-arm parallel pilot rct design. a total of 60 young adults with fasd will be randomly assigned into the (1) thrive intervention or the (2) waitlist comparison group using a 50:50 allocation ratio. as this is a type 1 hybrid trial, measurement emphasizes effectiveness outcomes, with collection of some implementation outcomes/process to inform planning of subsequent larger scale community trials. consistent with the pilot rct design, analysis will focus on determining feasibility of the intervention, trial procedures and measurement, and intervention process. this information will optimize success of the planned r01 larger-scale rct.

Eligibility criteria:
inclusion criteria: * young adult between the ages of 18 and 25 * lives in the united states * has a diagnosis of fetal alcohol spectrum disorder or confirmed prenatal alcohol exposure exclusion criteria: * does not have access to the internet or data plan allowing video conferencing * is not able to listen or speak in english

Keywords: fetal alcohol spectrum disorders person-centered planning
[18f]fluciclatide-pet, pazopanib and paclitaxel in ovarian cancer

Conditions: Ovarian Neoplasm

Summary: the purpose of this study is to assess \[18f\] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of relapsed ovarian cancer * responded to at least on one line of prior platinum based therapy * relapsed within platinum resistant interval (≤6months) * eastern cooperative oncology group (ecog) performance status of \<2 * measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques * satisfactory baseline haematologic and organ function: * haematologic: absolute neutrophil count \> or = 1.5 x 10\^9/l; platelets \> or = 100 x 10\^9/l; haemoglobin \> or = 9g/dl; pt or inr \< or = 1.2 x uln; ptt \< or = 1.2 x uln * hepatic: bilirubin \< or = 1.5 x uln; ast or alt \< or = 2.5 x uln * renal: serum creatinine \ 1.5 mg/dl, calculated creatinine clearance \> or = 50ml/min; upc \<1 exclusion criteria: * poorly controlled hypertension \[defined as systolic blood pressure (sbp) of ≥140 mmhg or diastolic blood pressure (dbp) of ≥ 90mmhg\]. note: initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. bp must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) sbp / dbp values from each bp assessment must be \<140/90 mmhg in order for a subject to be eligible for the study. * treatment with any of the following anti-cancer therapies: * radiation therapy 28 days prior to the first dose of pazopanib or * surgery or tumor embolization within 14 days prior to the first dose of pazopanib or * chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib * treatment with anti-angiogenic therapy * presence of gross ascites * clinically significant peripheral neuropathy * females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

Keywords: platinum resistant ovarian cancer
comparative evaluation of contact lens centering of dailies® aquacomfort plus® versus 1-day acuvue® moist® in japan

Conditions: Refractive Error; Myopia; Myopic Astigmatism

Summary: the purpose of this study is to evaluate lens centration and subjective impressions of dailies® aquacomfort plus® (dacp) lenses compared to 1-day acuvue® moist® (1dam) lenses in ball sports players.


Eligibility criteria:
inclusion criteria: * those who can understand the clinical study objectives and provide written informed consent. legal representative or parental consent required if under age 20 * those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week * those who play ball sports at least 1 day per week * those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction * other protocol-defined inclusion criteria may apply exclusion criteria: * those who regularly wear the study device * those who require ocular treatment with eye drops * those who have a condition contraindicating soft contact lens wear, such as eye irritation * those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study * those who are participating in another clinical study or research or have a plan of such participation during the present study * women who are pregnant or intend to become pregnant during the study * other protocol-defined exclusion criteria may apply

Keywords: soft contact lenses dacp
covid-19 and technology - the impact on clinical trial patients

Conditions: Cancer

Summary: this is a 2 part qualitative study involving a questionnaire (part 1) and focus group discussions (part 2). the purpose of the study is to evaluate how patients' attitudes to technology in the oncology clinical trials setting since the start of the coronavirus pandemic in 2020, and to assess how their use of technology has changed during this time. part 1 of the study will be conducted via a self-report questionnaire to 100-140 cancer patients involved in clinical trials at the christie nhs foundation trust over a 2 month period. following this, three focus groups with a maximum of 8 participants in each group will take place to further assess patients' experiences with technology during the pandemic. participants may take part in part 1 or part 2 only, or in both.

clinical trial involvement is more resource-intensive than receiving standard of care treatment and often results in more frequent hospital visits for patients. to reduce the risk of patients to covid-19, there has been a shift towards reducing on-site visits with increased use of technology e.g. virtual visits. patients may have also been using devices at home to aid in their care, including digital devices, mobile applications, smart watches and, rarely, trial-specific devices, to monitor aspects of their own health. our project will explore the impact that the coronavirus pandemic has had on clinical trial patients and how they feel technology could help or create barriers in their future care. in order to quantify how clinical trial visits have changed and to evaluate patient's attitudes to the increasing use of technology in clinical trials, we will be disseminating questionnaires to 100 patients currently on clinical trials over a 2 month period. we will follow these up with three virtual focus group discussions with 8 participants in each to delve further into patients' experiences.

Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: 1. patients have to be 18 years of age or older. 2. patients have to be currently enrolled on a phase i, ii or iii cancer related clinical trial within the christie nhs foundation trust exclusion criteria: participants are excluded from the study if any of the following criteria apply: 1. unable to understand and converse in english for the focus group session. 2. patient not currently involved in a phase i, ii or iii clinical trial
cardiac non invasive mapping in resynchronization

Conditions: Cardiac Resynchronization Therapy

Summary: non-invasive mapping using the cardio insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.

non-invasive mapping using the cardio insight system is prospectively performed routinely in heart failure patients requiring cardiac resynchronization therapy. control patients are included, requiring chronic permanent right ventricular pacing. specific focus include: optimization of programming parameters, pacing-induced cardiomyopathy, ventricular arrhythmias, defibrillation threshold testing and electrical shocks.

Eligibility criteria:
inclusion criteria: * patients implanted with a biventricular pacing device (crt) device * patients chronically implanted with a right ventricular pacing device. exclusion criteria: * age \<18 years

Keywords: non invasive mapping cardiac resynchronization therapy pacing-induced cardiomyopathy electrical shock
prevalence of mafld in patients with type 2 diabetes in jiangsu province of china

Conditions: Type 2 Diabetes Mellitus in Remission; Metabolic Associated Fatty Liver Disease

Summary: in 2019, the number of patients with diabetes was about 463 million in the world, accounting for 8.3% of the total population, and it is expected to rise to 578 million (9.2%) by 2030 and 700 million (9.6%) by 2045. according to the who diagnostic criteria, the prevalence of diabetes among adults in china from 2015 to 2017 was 11.2%, of which over 90% were type 2 diabetes mellitus (t2dm). the global prevalence of non-alcoholic fatty liver disease (nafld) is also very high, which was approximately 25% in 2016. the prevalence of nafld may continue to rise. nafld is often accompanied by clinical manifestations of metabolic syndrome, such as obesity, t2dm, hyperlipidemia and hypertension.

the presence of nafld not only increases the risk of t2dm, but also accelerates the process of various diabetes-related organ damage in patients with t2dm. similarly, t2dm also increases the risk of nafld. however, in patients with t2dm, there are few reports on the correlation between ultrasound attenuation parameters for non-invasive assessment of liver fat content and insulin resistance. in addition, t2dm may be the most important predictor of adverse clinical outcomes in nafld patients. t2dm is an important predictor of nafld patients progressing to compensated advanced chronic liver disease (cacld), and even cirrhotic portal hypertension and other end-stage liver diseases. in february 2020, international experts suggested nafld to be renamed metabolic associated fatty liver disease (mafld). in april of the same year, the journal of hepatology released a new definition and diagnosis of mafld with the criteria based on histological (liver biopsy), imaging, or blood biomarker indicating the presence of hepatic fat accumulation (hepatocyte steatosis), in combination with one of the following 3 conditions: overweight/obesity, type 2 diabetes and metabolic dysfunction. the new diagnostic criteria are based on underlying metabolic abnormalities and recognize that mafld often coexists with other diseases. therefore, this study aims to investigate the prevalence and clinical characteristics of mafld in patients with t2dm, as well as the correlation between uap and insulin resistance in t2dm. patients will be followed up to 5 years for the clinical outcomes at 3months, 6 months, 12 months, 36 months, 48 months and 60 months respectively and the risk factors affecting the clinical outcomes of patients with t2dm will be analyzed.

Eligibility criteria:
inclusion criteria: * diagnosed as t2dm according to the chinese guidelines for the prevention and treatment of type 2 diabetes * uap were measured based on ilivtouch * willing to attend this study and able to provide the written informed consent. exclusion criteria: * other types of diabetes * patients unable to receive regular follow-up

Keywords: type 2 diabetes mellitus metabolic associated fatty liver disease ultrasound attenuation parameter
post-marketing surveillance study of invasive mycosis with posaconazole (study p04641)

Conditions: Mycoses

Summary: the purpose of this postmarketing surveillance study is to collect an extensive body of data in a large patient population in every day life to investigate the safety and efficacy of noxafil® (posaconazole) in the treatment of invasive fungal disease.

data regarding demographics, underlying disease, prior fungal infection, prior antifungal medication, invasive fungal infection signs \& symptoms, concomitant medication, posaconazole use, tolerability, safety and therapy outcome will be collected on abstracted electronic case report forms. this surveillance study was originally limited to subjects receiving posaconazole as salvage antifungal therapy as indicated. a subgroup of subjects at risk for invasive fungal infection was included for prophylactic treatment following the enlargement of the marketing authorization for noxafil® (posaconazole) during the course of the study. these participants only contributed data for the assessment of safety.

Eligibility criteria:
inclusion criteria: adult subjects with: * invasive aspergillosis refractory to, or intolerant of, amphotericin b or itraconazole, * fusariosis refractory to, or intolerant of, amphotericin b, * chromoblastomycosis and mycetoma refractory to, or intolerant of, itraconazole, * coccidiomycosis refractory to, or intolerant of, amphotericin b, itraconazole or fluconazole. * subjects receiving remission-induction chemotherapy for acute myelogenous leukemia (aml) or myelodysplastic syndromes (mds) expected to result in prolonged neutropenia and who are at high risk for developing invasive fungal infections. * hematopoietic stem-cell transplant (hsct) recipients who are undergoing high-dose immunosuppressive therapy for graft-versus-host disease and who are at high risk for developing invasive fungal infections. exclusion criteria: * comedication of the participant with ergotamine, dihydroergotamine, terfenadine, astemizole, cisapride, pimozide, halofantrine, or chinidine.
a clinical study of mk-2870 alone or with chemotherapy to treat gastrointestinal cancers (mk-9999-02a)

Conditions: Colorectal Cancer; Pancreatic Ductal Adenocarcinoma; Biliary Tract Cancer

Summary: researchers want to learn if sacituzumab tirumotecan (mk-2870) alone or with chemotherapy can treat certain gastrointestinal (gi) cancers. the gi cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). the goals of this study are to learn: * about the safety and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy * how many people have the cancer respond (get smaller or go away) to treatment


Eligibility criteria:
inclusion criteria: the main inclusion criteria include but are not limited to the following: * has one of the following cancers: * unresectable or metastatic colorectal cancer * advanced or metastatic pancreatic ductal adenocarcinoma (pdac) * advanced and/or unresectable biliary tract cancer (btc) * has received prior therapy for the cancer * has recovered from any side effects due to previous cancer treatment exclusion criteria: the main exclusion criteria include but are not limited to the following: * history of severe eye disease * received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention * history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
glycemic durability after metformin failure

Conditions: Type 2 Diabetes

Summary: type 2 diabetes is epidemic and its treatment has become more and more difficult. consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin a1c (hba1c) of \<7%. amazing, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.

* source data verification: paper or electronic medical records. * statistical analysis: all analyses will compare the randomly assigned treatment groups under the intention- to-treat principle

Eligibility criteria:
inclusion criteria: * newly-diagnosed, type 2 diabetic patients, failing to diet exclusion criteria: * suspected type 1 diabetes or secondary diabetes resulting from specific causes * current or previous (within past 3 months) treatment with any investigational drug * any major cardiovascular event in previous year * plans for pregnancy during the course of the study for women of childbearing potential * serum creatinine level \>1.3 mg/dl in women and \>1.4 mg/dl in men * history of cancer, other than nonmelanoma skin cancer, that required therapy in the 5 years before randomization * treatment with oral, loal, systemic glucocorticoids 14. treatment with atypical antipsychotics
trial comparing loop ileostomy versus loop transverse colostomy

Conditions: Rectal Neoplasms; Ostomy; Neoplasms

Summary: the purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.

the investigators enroll patients with a histologically confirmed diagnosis of primary rectal cancer with or without prior chemoradiotherapy who were hospitalized at the ufa republican clinical oncology center from february 2023 to february 2024. all patients undergo planned laparoscopic or open low-anterior resection of the rectum with total mesorectal excision. patients are randomized into 2 groups in a 1:1 ratio. in the first group, a loop transverse colostomy is created, and in the second group, a loop ileostomy is created. the stoma exit sites are marked in advance the day before the surgery. the bowels are prepared by mechanical means (a polyethylene glycol-based laxative with a cleansing enema) according to a standard procedure before the surgery. standardized stoma creation techniques are used. the resected parts are collected through a separate access. patients are followed up for 60 days after surgery. the sample size should be 124 patients to reach statistical significance (α = 0.05, study power 80%, confidence interval (ci) = 95%.). considering possible losses during the study, the number of patients was increased to 130. the investigators hypothesis is that the loop ileostomy group has a 20% higher incidence of stoma dysfunction but a 20% lower incidence of ssi (stoma site infections) compared to the loop colostomy group.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to mri) * ecog status 0-2, * asa≤3. * at least 18 years of age * written informed consent exclusion criteria: * emergency surgery; * previously formed stoma; * stage 4 disease; * obstructive resection of the rectum; * patients older than 79 years

Keywords: rectal cancer low anterior resection loop transverse colostomy loop ileostomy stoma site infections
compare different cervical anterior discectomy procedures by after procedure sagittal alignment on radiograph

Conditions: Cervical Disc Degeneration

Summary: patients with single-level cervical degenerative disc disease commonly undertook anterior discectomy. to compare the effect of anterior cervical discectomy without fusion (acd), anterior cervical discectomy with fusion by stand-alone cage (acdf) or anterior cervical discectomy with arthroplasty (acda)， a multiple center randomised controlled trial will be performed in patients with single-level cervical disease. the primary outcome will be cervical alignment by upright cervical spine radiographs estimated by harrison posterior tangent method.

this study will use a multiple center open-label randomised controlled trial to estimate the effect of acd, acdf, acda for single-level cervical degenerative disc. patients with arm pain not responding to conservative treatment take part in this trial. they will be randomised assigned into 3 parallel arms. the participants in the each arm will undertake acd acdf or acda. the baseline is the day of surgery. the harrison posterior tangent method was used as an estimate for measuring cervical alignment. the primary outcome will be the cervical sagittal alignment estimated by harrison posterior tangent method.

Eligibility criteria:
inclusion criteria: * patients with arm pain not responding to conservative treatment * lasted longer than 10 weeks * single level disc degeneration * mobile spine on dynamic lateral cervical x-rays exclusion criteria: * severe cardiopulmonary comorbidity * suspected underlying malignant disease * radicular syndrome * spinal-cord compression syndrome * contraindication for radiography

Keywords: cervical disc degeneration cervical anterior discectomy spinal alignment